Risk of myocarditis and pericarditis after the COVID-19 mRNA vaccination in the USA: a cohort study in claims databases.

Background: Several passive surveillance systems reported increased risks of myocarditis or pericarditis, or both, after COVID-19 mRNA vaccination, especially in young men. We used active surveillance from large health-care databases to quantify and enable the direct comparison of the risk of myocarditis or pericarditis, or both, after mRNA-1273 (Moderna) and BNT162b2 (Pfizer-BioNTech) vaccinations.

Methods: We conducted a retrospective cohort study, examining the primary outcome of myocarditis or pericarditis, or both, identified using the International Classification of Diseases diagnosis codes, occurring 1-7 days post-vaccination, evaluated in COVID-19 mRNA vaccinees aged 18-64 years using health plan claims databases in the USA.

ISPOR, the FDA, and the Evolving Regulatory Science of Medical Device Products.

The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is a key venue for members from private industry, government, and academia to collaborate and share advances in regulatory, clinical, and reimbursement science for drugs, devices, and diagnostics. In parallel, the US Food and Drug Administration (FDA) "is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable." In 2012, the Medical Device Innovation Consortium (MDIC) was formed as a public-private partnership bringing together government, industry, and nonprofit organizations to advance approaches that promote patient access to safe, innovative medical technologies.

Multi-gene assays: effect on chemotherapy use, toxicity and cost in estrogen receptor-positive early stage breast cancer.

Aim: To assess multi-gene assay (MGA) effects on chemotherapy use, toxicities, recurrences, and costs in estrogen receptor-positive early breast cancer.

Methods: Meta-analysis performed using data from public databases. Results: Studies included 12,202 women.

Correction to: Early nuclear stress testing after CABG: The new standard or too soon to tell?

The Disclosure section should be updated to read: "The views expressed in this article are those of the author and do not reflect the official policy of the Department of Army/Navy/Air Force, Department of Defense, or U.S. Government.

Balancing Confounding and Generalizability Using Observational, Real-world Data: 17-gene Genomic Prostate Score Assay Effect on Active Surveillance.

Randomized, controlled trials can provide high-quality, unbiased evidence for therapeutic interventions but are not always a practical or viable study design for certain healthcare decisions, such as those involving prognostic or predictive testing. Studies using large, real-world databases may be more appropriate and more generalizable to the intended target population of physicians and patients to answer these questions but carry potential for hidden bias. We illustrate several emerging methods of analyzing observational studies using propensity score matching (PSM) and coarsened exact matching (CEM).

A Promising New Strategy to Improve Treatment Outcomes for Patients with Depression.

Each year, ineffective medical management of patients with mental illness compromises the health and well-being of individuals, and also impacts communities and our society. A variety of interrelated factors have impeded the health system's ability to treat patients with behavior health conditions adequately. A key contributing factor is a lack of objective markers to help predict patient response to specific drugs that has led to patterns of "trial and error" prescribing.

Economic Analysis of a Noninvasive Molecular Pathologic Assay for Pigmented Skin Lesions.

Importance: A recently described noninvasive gene expression test (the pigmented lesion assay [PLA]) with adhesive patch-based sampling has the potential to rule out melanoma and the need for surgical biopsy of pigmented lesions suggestive of melanoma with a negative predictive value of 99% compared with 83% for the histopathologic standard of care. The cost implications of using this molecular test vs visual assessment followed by biopsy and histopathologic assessment (VAH) have not been evaluated.

Objective: To determine potential cost savings of PLA use vs the VAH pathway.

Legislative and Policy Developments and Imperatives for Advancing the Primary Care Behavioral Health (PCBH) Model.

The Primary Care Behavioral Health (PCBH) practice model continues to gain converts among primary care and behavioral health professionals as the evidence supporting its effectiveness continues to accumulate. Despite a growing number of practices and organizations using the model effectively, widespread implementation has been hampered by outmoded policies and regulatory barriers. As policymakers and legislators begin to recognize the contributions that PCBH model services make to the care of complex patients and the expansion of access to those in need of behavioral health interventions, some encouraging policy initiatives are emerging and the policy environment is becoming more favorable to implementation of the PCBH model.

Active Surveillance Use Among a Low-risk Prostate Cancer Population in a Large US Payer System: 17-Gene Genomic Prostate Score Versus Other Risk Stratification Methods.

Many men with low-risk prostate cancer (PCa) receive definitive treatment despite recommendations that have been informed by two large, randomized trials encouraging active surveillance (AS). We conducted a retrospective cohort study using the Optum™ Research Database (Eden Prairie, MN) of electronic health records and administrative claims data to assess AS use for patients tested with a 17-gene Genomic Prostate Score™ (GPS; Genomic Health, Redwood City, CA) assay and/or prostate magnetic resonance imaging (MRI). De-identified records were extracted on health plan members enrolled from June 2013 to June 2016 who had ≥1 record of PCa (n 5 291,876).

Financing the Primary Care Behavioral Health Model.

The PCBH model of integrated care blends behavioral health professionals into the primary care team, thereby enhancing the scope of primary care and expanding the range of services provided to the patient. Despite promising evidence in support of the model and a growing number of advocates and practitioners of PCBH integration, current reimbursement policies are not always favorable. As the nation's healthcare system transitions to value-based payment models, new financing strategies are emerging which will further support the viability of PCBH integration.

From Drug Safety to Drug Security: A Contemporary Shift in the Policing of Health.

The counterfeiting of medication is increasingly seen as a major threat to health, especially in the light of both the everyday reliance on and a broadening of world-wide access to pharmaceuticals. Exaggerated or real, this threat has inaugurated, this article argues, a shift from a drug safety regime to a drug security regime that governs the flow of pharmaceuticals and brings together markets, police, and health actors in new ways. This entails a shift from soft disciplinary means aimed at incremental and continued inclusion of defaulters, to one of drastically sovereign measures of exclusion and banishment aimed at fake goods and the people associated with them, in the name of health.

Prospective, multicenter French study evaluating the clinical impact of the Breast Cancer Intrinsic Subtype-Prosigna® Test in the management of early-stage breast cancers.

Purpose: The Prosigna® breast cancer prognostic gene signature assay identifies a gene-expression profile that permits the classification of tumors into subtypes and gives a score for the risk of recurrence (ROR) at 10 years. The primary objective of this multicenter study was to evaluate the impact of Prosigna's assay information on physicians' adjuvant treatment decisions in patients with early-stage breast cancer. Secondary objectives were to assess confidence of practitioners in their therapeutic recommendations before and after the added information provided by the Prosigna assay; and to evaluate the emotional state of patients before and after the Prosigna test results.

Serious Adverse Events Associated with Readmission Through One Year After Vertebral Augmentation with Either a Polyetheretherketone Implant or Balloon Kyphoplasty.

Background: The KAST (Kiva Safety and Efficacy) investigation device exempt (IDE) study indicated that the majority of patients responded equally well to vertebral augmentation using either an implant-based approach or balloon kyphoplasty (BK). Additional investigation has suggested that a subset of patients may benefit further by avoiding repeated readmissions due to serious adverse events (SAEs) if they receive one vertebral augmentation approach over another.

Objectives: The primary aim was to assess the effect of 2 different augmentation procedures on readmission rates for SAEs.

Urine circulating-tumor DNA (ctDNA) detection of acquired EGFR T790M mutation in non-small-cell lung cancer: An outcomes and total cost-of-care analysis.

Objectives: Third-generation tyrosine kinase inhibitors (TKIs) have proven effective in patients with the acquired EGFR T790M resistance mutation who progress on prior EGFR TKI therapy. Median progression-free survival (PFS) on a 3rd-gen TKI was 9-10 months for T790M+ patients compared to 2.8 months for T790M- patients.

The Burden of Mental Disorders in the Eastern Mediterranean Region, 1990-2013.

The Eastern Mediterranean Region (EMR) is witnessing an increase in chronic disorders, including mental illness. With ongoing unrest, this is expected to rise. This is the first study to quantify the burden of mental disorders in the EMR.

Clinical and cost implications of amyloid beta detection with amyloid beta positron emission tomography imaging in early Alzheimer's disease - the case of florbetapir.

Objective: Amyloid beta (Aβ) positron emission tomography (PET) imaging helps estimate Aβ neuritic plaque density in patients with cognitive impairment who are under evaluation for Alzheimer's disease (AD). This study aims to evaluate the cost-effectiveness of the Aβ-PET scan as an adjunct to standard diagnostic assessment for diagnosis of AD in France, using florbetapir as an example.

Methods: A state-transition probability analysis was developed adopting the French Health Technology Assessment (HTA) perspective per guidance.

In vitro characterization of acelluar porcine adipose tissue matrix for use as a tissue regenerative scaffold.

This study evaluated a novel approach to decellularizing porcine adipose tissue while preserving its 3-D architecture. An ethanol-water mixture was used as a solvent to remove lipids and the number of freeze-thaw cycles (1-7), ethanol concentration, and tissue thickness were tested. Trypsin incubation time (1-3 h) and xylene immersion time were investigated separately.

Reconstruction of Temporal Hollowing Defect With Anterior-Lateral Thigh Free Flap Following Resection of Recurrent Ameloblastoma of the Infratemporal Fossa and Right Mandible (a Case Report).

Recurrent invasive ameloblastoma of the infratemporal fossa is an uncommonly encountered phenomenon in the practice of oral and maxillofacial surgery and presents many surgical challenges for the practitioner. This case report describes a patient who underwent previous resection of a mandibular ameloblastoma with multiple recurrences. The patient was diagnosed with a recurrent ameloblastoma of the infratemporal fossa that was subsequently resected and reconstructed using an anterolateral thigh (ALT) free tissue transfer.

The West German Study Group Breast Cancer Intrinsic Subtype study: a prospective multicenter decision impact study utilizing the Prosigna assay for adjuvant treatment decision-making in estrogen-receptor-positive, HER2-negative early-stage breast cancer.

Purpose: The West German Study Group (WSG) Breast Cancer Intrinsic Subtype (BCIST) study was designed to assess the influence of Prosigna gene signature assay results on physicians' adjuvant treatment recommendations by determining the extent of change in pre-test treatment recommendations following assay results. Secondary objectives were to assess the influence of Prosigna results on physicians' confidence in their therapeutic recommendations and on patients' decisional conflict status, anxiety levels, and functional status.

Methods: This prospective, observational, decision impact study enrolled consecutive postmenopausal patients with estrogen-receptor (ER)-positive, HER2-negative, lymph-node-negative early-stage breast cancer in 11 centers in Germany.